DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application was filed 02 May 2023 and claims benefit to provisional applications 63/337,960 and 63/348,852 filed 03 May 2022 and 03 June 2022 respectively. Therefore, the effective filing date of the instant application is 03 May 2022.
Election/Restrictions
Applicant’s election of 7HP349 and Formula (I) wherein q =3 in the reply filed on 22 October 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
New claims 44 and 45 are interpreted as species of Formula (II). Since the Applicant elected 7HP349 of Formula (I), the claims are withdrawn from consideration.
Examiner’s Note
The Applicant's amendments and arguments filed 30 January 2026 and 18 February 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s responses, filed 30 January 2026 and 18 February 2026, it is noted that claims 24, 25, 27, 29, 30, 32, 33, 35-39, 41, and 43 have been amended, claim 40 has been canceled, and claims 44-47 have been newly added. Support for the amendment(s) and/or new claim(s) can be found in para. 90 of the specification. No new matter has been added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 23-29, 31-40, 42, 43, 46, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodside et al. (US 10342866 B2), Zimmerman (WO 2021/195319 A1), and clinicalgate.com.
Woodside teaches an integrin pharmaceutical composition with a suitable carrier (col. 3, ln. 8; entire teaching) and may comprise a compound that is also known as 7HP349 (col. 37, Table I in Woodside; structure and compound name evidenced by probechem.com, pg. 1), which is capable of enhancing integrin-mediated binding of integrins of a cell to their ligands, where the integrins include α4β1, α4β7, α5β1, and/or αLβ2, where the ligands include VCAM-1, fibronectin, MAdCAM-1, ICAM-1, and/or ICAM-2 (col. 8, lns. 39-48). The Applicant’s election of 7HP349 is interpreted as addressing claims 23, 32, 34, 43, and partially claims 1 and 33 regarding the solubility of the integrin agonist. The composition may comprise an emulsifier and solvent (col. 6, ln. 65-col. 7, ln. 3). The formulation may be administered by enteral or parenteral route (col. 9, lns. 22-23).
The structure of 7HP349 (evidenced by probechem.com, pg. 1):
PNG
media_image1.png
177
316
media_image1.png
Greyscale
Woodside does not specifically teach a zwitterionic surfactant, neutral lipid, and polar organic solvent in at least claims 1 and 33.
Zimmerman teaches a drug carrier system for releasing biologically active agents that may be insoluble in water (abs, para. 125). The composition may comprise zwitterionic surfactants, such as betaines, sulfobetaines (para. 167), phosphatidylcholine or lecithin (para. 7) in an amount of at least 10% (para. 8), neutral lipids, such as triglycerides, methanol, ethanol (para. 179), and medium chain triglycerides (para. 181, 186) in an amount of about 30-75% (para. 184), and solvents, such as PPG or DMSO (para. 186) in an amount of less than 10% (para. 23), addressing claims 24, 25, 35, and 36. The composition may further comprise oleic acid (para. 11, 129) in an amount of about 5% (par. 9), addressing claims 28 and 39, and up to 40% of a nonionic surfactant, cationic surfactant, or anionic surfactant (para. 113), addressing claims 29 and 40. Other possible ingredients include vitamin A, aluminum, non-toxic dye, and a flavor enhancer (para. 21, 110), addressing claims 31 and 42. The formulation may be administered parenterally or orally (para. 83). Triglycerides in an amount of about 30-75%, surfactants in an amount of up to 40%, and less than 10% of a polar solvent are interpreted as addressing the amounts in claims 46 and 47.
Clinicalgate.com teaches that ethanol is the most common organic solvent used in pharmaceutical solutions, especially in topical, parenteral, oral, and otic solutions (pg. 3).
Since Woodside does not specifically teach a zwitterionic surfactant, neutral lipid, and polar organic solvent in at least claims 1, 26, 27, 33, 36-38, but does teach an emulsifier (col. 6, ln. 67), one of ordinary skill in the art would have been motivated to use Zimmerman’s teaching of a zwitterionic surfactant, neutral lipid, organic solvent, oleic acid, vitamin A, aluminum, a non-toxic dye, and a flavor enhancer, as well as clinicalgate.com’s teaching of an alcohol, such as ethanol, as a common solvent in drug delivery systems. A skilled artisan would have been led to combine the teachings since Zimmerman teaches a drug carrier system for biological active agents that are insoluble in water, Woodside teaches a pharmaceutical composition with a suitable carrier, emulsifier, and a compound, such as 7HP349, that is poorly soluble in water, and clinicalgate.com teaches that ethanol is commonly used in pharmaceutical drug delivery systems for many types of solutions and administrations. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Claim(s) 1, 23-43, 46, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woodside et al. (US 10342866 B2), Zimmerman (WO 2021/195319 A1), clinicalgate.com, and spipharma.com.
In regards to claim(s) 1, 23-29, 31-40, 42, 43, 46, and 47, Woodside and Zimmerman, as applied supra, is herein applied in its entirety for its teachings of an integrin pharmaceutical composition with a suitable carrier (col. 3, ln. 8; entire teaching) comprising 7HP349 (col. 37, Table I).
Woodside does not specifically teach gelatin and a sorbitol-glycerin blend in their composition in claims 30 and 41.
Spipharma.com teaches that gelatin and a sorbitol-glycerin blend are common plasticizers and ingredients used in oral formulations, such as capsules, and may provide advantages such as convenience, cost, bioavailability, and solubility (pgs. 1-2).
The limitation of gelatin and sorbitol-glycerin stabilizing emulsions when added to an aqueous injectable carrier to form an injectable composition in claims 30 and 41 is interpreted as a functional property of the composition. Since the properties cannot be separated from the composition and if the components are present, then the composition will necessarily have the effect, based on the broadest reasonable interpretation of a system claim having a structure that performs a function (see MPEP 2111.04 II).
Since Woodside does not specifically teach gelatin and a sorbitol-glycerin blend in their composition in claims 30 and 41, one of ordinary skill in the art would have been motivated to use spipharma.com’s teaching of gelatin and sorbitol-glycerin blend to improve bioavailability and solubility. A skilled artisan would have been led to combine the teachings to improve the compositions taught in Woodside’s and Zimmerman’s formulations for oral delivery.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
The Applicant argues that Zimmerman does not teach methanol or ethanol as organic solvents, but as ingredients to make fatty acid esters (Remarks, pgs. 22-23).
Applicant’s argument is not found persuasive. The compositions taught in Woodside and Zimmerman are both capable of incorporating a solvent. Clinicalgate.com teaches that ethanol is the most common organic solvent used in pharmaceutical solutions, especially in topical, parenteral, oral, and otic solutions (pg. 3). Therefore, a skilled artisan would have been led to combine the teachings since Zimmerman teaches a drug carrier system for biological active agents that are insoluble in water, Woodside teaches a pharmaceutical composition with a suitable carrier, emulsifier, and a compound, such as 7HP349, that is poorly soluble in water, and clinicalgate.com teaches that ethanol is commonly used in pharmaceutical drug delivery systems for many types of solutions and administrations.
The Applicant argues that Zimmerman teaches that DMSO and PPG are used as surface-active agents and not solvents (Remarks, pg. 24),
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123). DMSO and PPG are both common polar solvents well-known in the art. Therefore, the general and broad teaching in Zimmerman is understood to include DMSO and PPG as possible polar solvents used in their composition.
The Applicant argues that the amendments in claims 30 and 41 are not taught in the art (Remarks, pgs. 25).
Applicant’s argument is not found persuasive. The limitation of gelatin and sorbitol-glycerin stabilizing emulsions when added to an aqueous injectable carrier to form an injectable composition in claims 30 and 41 is interpreted as a functional property of the composition. Since the properties cannot be separated from the composition and if the components are present, then the composition will necessarily have the effect, based on the broadest reasonable interpretation of a system claim having a structure that performs a function (see MPEP 2111.04 II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
Prosecution Insights